USP and Public Policy
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USP appreciates the opportunity to comment on the proposed revision to the above-captioned Circular on voluntary consensus standards.
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USP appreciates the opportunity to discuss drug naming at the Federal Trade Commission’s (FTC’s) recent workshop on Follow-On Biologics. USP appreciates FTC’s efforts to help ensure access to quality…
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USP appreciates the opportunity to comment on the above-captioned proposed rule related to implementation of the Foods Safety Modernization Act (FSMA) -- preventive controls.
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USP appreciates the public meeting held by the Food and Drug Administration (FDA) on June 19 to seek input on FDA's international capacity building plan under the FSMA.
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USP Comment Letter: Submitted to FDA on FDA’s International Capacity Building Plan under FSMA (2012)
USP appreciates the public meeting held by the Food and Drug Administration (FDA) on June 19 to seek input on FDA's international capacity building plan under the FSMA.
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The following are comments of the USP in response to the above-referenced draft Guidance for Industry on post-approval manufacturing changes reportable in annual reports under 21 CFR §314.70.
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USP appreciates the opportunity to provide input as the Food and Drug Administration (FDA) proceeds with implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
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